Regulatory Affairs Associate – Pharmaceutical

About the role

Dawa Life Sciences is seeking a Regulatory Affairs Associate to support the registration and maintenance of pharmaceutical products for African markets. You will work closely with production, quality, and development teams to ensure compliance with local and regional regulations.

Key responsibilities

• Prepare, review, and submit product dossiers through each authority’s portal.
• Manage product licence variations and renewals to keep products on the market.
• Coordinate packaging artwork, labels, inserts, and leaflets to meet country‑specific labelling requirements.
• Collaborate with Production, PD, QA, and QC on batch manufacturing records, stability data, validation reports, and methods of analysis.
• Monitor changes in Kenyan and regional pharmaceutical regulations and advise the business.
• Serve as the primary contact for regulators and compile technical responses.
• Obtain GMP certificates and import/export permits, maintaining audit‑ready records.

Required profile

• Diploma or bachelor’s degree in Pharmacy, Chemistry, Biochemistry, Pharmaceutical Sciences or a related field.
• 4–5 years of regulatory affairs experience in pharmaceutical manufacturing.
• Registration with the Pharmacy and Poisons Board or a relevant professional body.
• Strong technical writing, communication, analytical and organizational abilities.

Required skills

• Good Manufacturing Practice (GMP)
• Good Laboratory Practice (GLP)
• Good Distribution Practice (GDP)
• Familiarity with regulatory portals and document management systems
• Technical writing